IMPORTANT: Please read carefully and keep this information for future use.

Transcription

1 IMPORTANT: Please read carefully and keep this information for future use. This fitting guide is intended for the eyecare practitioner, but should be made available to the patient upon request. The eyecare practitioner should provide the patient with the wearer's guide that pertains to the patients prescribed lens. eyedia precise monthly for astigmatism (HIOXIFILCON A) DAILY WEAR SOFT CONTACT LENS CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED PRACITIONER clearlab is trademark of Clearlab SG Pte. Ltd. and eyedia is trademark of Clearlab US, Inc. Page 1 of 16

2 Table of Contents Title Introduction Product Description Lens Parameters Available Actions Indications Contraindications, Warnings, Precautions, and Adverse Reactions Selection of Patients Fitting Procedure Outline Pre-Fitting Examination Parameter Selection Follow-up Care In-Office Care of Trial Lenses Recommended Initial Wearing Schedule Frequent/Planned Replacement Recommended Lens Care Products Clinical Assessment Criteria of a Well-fitted Lens Characteristics of a Tight (Steep) Lens Characteristics of a Loose (Flat) Lens Monovision Fitting Guidelines Patient Lens Care Directions Emergencies Reporting of Adverse Reactions How Supplied Symbols Key Page 2 of 16

3 INTRODUCTION: The eyedia precise monthly for astigmatism (Hioxifilcon A) Soft (hydrophilic) Contact Lens is made from Hioxifilcon A with a water content of 57% by weight. For a complete listing of available lens parameters, please refer to LENS PARAMETERS AVAILABLE. PRODUCT DESCRIPTION: The eyedia precise monthly for astigmatism (Hioxifilcon A) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2-hydroxythyl methacrylate and 2,3-dihydroxypropyl methacrylate, cross linked with ethylene glycol dimethacrylate. It consists of 43% hioxifilcon A and 57% water by weight when immersed in buffered saline solution. The lens is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution. The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 57% water by weight. The physical properties of the lens are: Refractive Index (wet) Light Transmission greater than 95% Water Content 57 % Specific Gravity (hydrated) Oxygen Permeability 20.0 x10-11 (cm 2 /sec) (ml O 2 /ml x mm 35 C), (Fatt Method, IS ). Page 3 of 16

4 LENS PARAMETER AVAILABLE: The lenses are hemispherical flexible shells which cover the cornea and portion of the adjacent sclera with the following dimensions: Chord Diameter : mm Center Thickness : 0.08 mm Base Curve : mm Powers : 0.0 to Diopters in 0.25 D increments to Diopters in 0.50 D increments to Diopters in 0.25 D increments to Diopters in 0.50 D increments Cylinders : D, D, D Axis : 80, 90, 100, 20, 10, 180, 170, 160 ACTIONS: In its hydrated state, the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens, when placed on the cornea, act as a refracting medium to focus light rays on the retina. The (toric) lens provides a more even surface over the highly uneven astigmatic cornea and thus helps to focus light rays on the retina. INDICATIONS: The eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement (see WEARING SCHEDULE). When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS SECTIONS: See package insert for Contraindications (Reasons Not to Use), Warnings, Precautions and Adverse Reactions. SELECTION OF PATIENT: Patient communication is vital. Patients who require visual correction but cannot adhere to the recommended care of the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens should not be provided with this lens. All necessary steps in lens care Page 4 of 16

5 and all precautions and warnings should be discussed and understood by the patient (Review Package Insert with patient). FITTING PROCEDURE OUTLINE: 1. Pre-Fitting Examination 2. Parameter Selection 3. Follow-up Care Fitting procedure for the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft (hydrophilic) Contact Lens. 1) Pre-fitting Examination A pre-fitting patient history and examination are necessary to: Determine whether a patient is a suitable candidate for daily wear contact lenses (refer to contraindications; consider patient hygiene and mental and physical state). Collect and record baseline clinical information to which post-fitting examination results can be compared. Make ocular measurements for initial contact lens parameter selection. 2) Parameter Selection The preferred fitting method is by use of a trial lens, selecting the steeper base curve as first choice and then evaluates the CRITERIA OF A WELL FITTED LENS. The alternative method is to determine the K readings and apply the following Average K Reading Suggested Lens Design and higher 8.6 mm base curve / 14.2 mm Diameter Lens power can be calculated from spectacle Rx Sphere Lenses: First convert the spectacle Rx in minus cylinder form (if applicable), compensate the power of both major meridians for a vertex distance of 0mm and then add half the cylinder power to the sphere Example: Rx at 12mm vertex distance x180 Power on horizontal meridians 12 mm vertex compensate to 0 vertex Power on vertical meridians 12 min vertex compensate to 0 vertex Rx at 0mm vertex distance -4.75, x180 Add half the cylinder to the sphere and round to the higher 0.25 step (-4.75) + (-0.75/2) = final power of the lens Page 5 of 16

6 3) Follow-up Care: a) Follow-up examinations are recommended by the eyecare practitioner, they are necessary to ensure continued successful contact lens wear. b) Prior to a follow up examination, the contact lens should be worn for at least one continuous hour and the patient should be asked to identify any problems which might be occurring related to contact lens wear. c) With lenses in place on the eyes, evaluate the fitting performance to assure the criteria of a well-fitted lens continue to be satisfied. Examine the lenses closely for surface deposition and / or damage. d) After the lens removal, conduct a thorough bio-microscopy examination. 1. The presence of vertical corneal striate in the posterior central cornea and/ or cornea neovascularization is indicative of excessive corneal edema. 2. The presence of corneal staining and / or limbal-conjunctival hypereremia can be indicative of an unclean lens, a reaction to solution preservatives, excessive lens wear and/ or a poorly fitting lens. 3. Papillary conjunctiva1 changes may be indicative of an unclean and/ or damaged lens. If any of the above observations are considered as abnormal, various professional judgments are necessary to alleviate the problem and restore the eye to its optimal conditions. If the Criteria of a Well-Fitted Lens is not satisfied during any follow-up examinations, the patient should be refitted with a more appropriate lens. FOLLOW - UP EXAMINATIONS: Within one week of lens dispensing After three weeks of lens wear After seven weeks of lens wear After each six month period of lens wear At the follow up examinations, the patient should report good subjective quality of vision. Adaptation to the vision with eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens should occur almost immediately and should definitely be reported within the first (1 week) follow-up visit. At these follow-up visits the practitioner should: 1. Check distance and near acuity with lens in place 2. Over-refract to verify lens prescription 3. Observe position of lens on the cornea. The lens should be centered and move on upward gaze and with blink. 4. Evert the lids to examine the tarsal conjunctiva and check for incidence of giant papillary conjunctivitis. 5. Remove the lens. Check corneal curvature. There should be no substantial changes in either meridian 6. Perform a slit-lamp examination with and without Fluorescein. Check for corneal edema, corneal abrasion, vascularization, corneal infiltrates and perilimbal injection. Reinsert the lens only after all residual Fluorescein has dissipated from the eye. Page 6 of 16

7 7. Clean the lens with a prophylactic surfactant cleaner and examine for deposits, foreign bodies or physical imperfections of the lens surface. IN OFFICE CARE OF TRIAL LENSES: Eyecare practitioners should educate contact lens technicians concerning proper care of trial lenses. For eyedia precise monthly for astigmatism (Hioxifilcon A) Soft (hydrophilic) Contact Lens, Each contact lens is shipped sterile in sealed blister packs containing the sterile buffered normal saline solution and labeled to the parameters of the lens contained. Hands should be thoroughly washed and rinsed dried with a lint free towel prior to handling a lens. In order to insure sterility, the sterile pack should not be opened until immediately prior to use. To open the blister pack pull back the lid where indicated. Upon removing the cover the lens may be removed and is ready for use. LENS HANDLING (in-office cleaning, disinfecting and storage): Wash and rinse hands thoroughly, making certain that all soap residues have been rinsed away before drying with a lint free towel. It is suggested to wet the lens while in the eye using wetting drops before removal. Always start with the right eye first in order to avoid mixing the lenses. When handling the lens, try to avoid touching the inside (concave) surface of the lens. It is possible, though not likely, that the lens might be inside out; therefore, check the lens by placing it on the index finger and examine its profile. If the edges of the lens tend to point outward, the lens is inside out. After removing the lens from its container assure that it is clean, clear and wet. eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens are not reused in diagnostic procedures. RECOMMENDED INITIAL WEARING SCHEDULE: Close professional supervision is recommended to ensure safe and successful contact lens wear. Although many practitioners have developed their own initial wearing schedules, the following sequence is recommended as a guideline. Patient should be cautioned to carefully follow the wearing schedule recommended by the eyecare practitioner regardless of how comfortable the lenses feel. If the patient complains of discomfort, decreased vision, ocular injection or corneal edema, the lens should be removed and the patient scheduled for examination. The problem may be relieved by putting the patient on a different wearing schedule or possibly by refitting the lens. THE WEARING AND REPLACEMENT SCHEDULES SHOULD BE DETERMINED BY THE EYECARE PRACTITIONER. Patients tend to overwear the lens initially. The eyecare practitioner should emphasize the importance of adhering to the initial maximum wearing schedule. It is important not to Page 7 of 16

8 exceed the wearing schedule. Regular check ups, as determined by the eyecare practitioner, are also extremely important. The maximum suggested wearing schedule for the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens is suggested below. DAY HOURS All Waking hours STUDIES HAVE NOT BEEN COMPLETED TO SHOW THAT THE eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens IS SAFE TO WEAR DURING SLEEP. FREQUENT/PLANNED REPLACEMENT: It is recommended that the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens be discarded and replaced with a new lens every two weeks. However, as the eyecare practitioner, you are encouraged to determine an appropriate lens replacement schedule based upon the response of the patient. RECOMMENDED LENS CARE PRODUCTS: The eyecare practitioner should recommend a care system that is appropriate for the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens. Each lens care product contains specific instructions for use and important safety information, which should be read and carefully followed. CLINICAL ASSESSMENT: 1. Criteria of a Well-Fitted Lens The criteria of a well fitted lens is one which centers easily after a blink, bridges the limbus and extends onto the sclera about 1.25mm, lags downward about 1.0 to 1.5 mm on upward gaze and does not move excessively as a result of blinking or exaggerated eye movements After the trial lens has settled on the eye (5-10minutes), manipulate the lens using lid pressure and observe for indications of excessive tightness. The lens should move freely and easily with slightest pressure and return to the centered position when released. Movement of the lens on the eye is very important in assessing the fit and performance of the lens. In primary gaze, slight vertical post-blinking lens movement should occur. On upward gaze, the lens should sag approximately min. 2. Characteristics of a Tight (Steep) Lens A tight (steep) lens does not move easily on the cornea with slight pressure. 3. Characteristics of a Loose (Flat) Lens Page 8 of 16

9 A loose (flat) lens sags more than 2.0 mm on upward gaze. MONOVISION FITTING GUIDELINES: 1. Patient Selection Page 9 of 16 A. Monovision Needs Assessment For a good prognosis the patient should have adequately corrected distance and near visual acuity in each eye. The amblyopic patient may not be a good candidate for monovision correction with the eyedia precise monthly for astifmatism (Hioxifilcon A) Soft Contact Lens. Occupational and environment visual demands should be considered. If the patient requires critical vision (visual acuity and stereopsis) it should be determined by trial whether this patient can function adequately with monovision. Monovision contact lens wear may not be optimal for such activities as: (1) visually demanding situations such as operating potentially dangerous machinery or performing other potential hazardous activities; and (2) driving automobiles (eg. driving at night). Patients who cannot pass their state drivers license requirements with monovision correction should be advised not to drive with this correction, or may require that additional over-correction be prescribed. B. Patient Education All patients do not function equally well with monovision correction. Patients may not perform as well for certain tasks with this correction as they have with bifocal reading glasses. Each patient should understand that monovision, as well as other presbyopic contact lenses, or other alternative, can create a vision compromise that may reduce visual acuity and depth perception for distance and near tasks. During the fitting process it is necessary for the patient to realize the disadvantages as well as the advantages of clear near vision in straight ahead and upward gaze that monovision contact lenses provide. 2. Eye Selection Generally, the non-dominant eye is corrected for near vision. The following test for eye dominance can be used. A. Ocular Preference Determination Methods Method 1 Determine which eye is the sight eye. Have the patient point to an object at the far end of the room. Cover one eye. If the patient is still pointing directly at the object, the eye being used is the dominant (sighting) eye.

10 Method 2 Determine which eye will accept the added power with the least reduction in vision. Place a trial spectacle near add lens in front of one eye and then the other while the distance refractive error correction is in place for both eyes. Determine whether the patient functions best with the near add lens over the right or left eye. B. Refractive Error Method For anisometropic corrections, it is generally best to fit the more hyperopic (less myopic) eye for distance and the more myopic (less hyperopic) eye for near. C. Visual Demands Method Consider the patient s occupation during the eye selection process to determine the critical vision requirements. If a patient s gaze for near tasks is usually in one direction correct the eye on that side of near. Example: A secretary who places copy to the left side of the desk will usually function best with the near lens on the left eye. 3. Special Fitting Consideration Unilateral Lens Correction: There are circumstances where only one contact lens is required. As an example, an emmetropic patient would only require a near lens while a bilateral myope may require only a distance lens. Example: A presbyopic emmetropic patient who requires a diopter add would have a lens on the near eye and the other eye left without a lens. A presbyopic patient requiring a diopter add who is diopter myopic in the right eye and diopter myopic in the left eye may have the right eye corrected for distance and the left uncorrected for near. 4. Near Add Determination Always prescribe the lens power for the near eye that provides optimal near acuity at the midpoint of the patient s habitual reading distance. However, when more than one power provides optical reading performance, prescribe the least plus (most minus) of the power. 5. Trial Lens Fitting Page 10 of 16

11 Page 11 of 16 A trial fitting is performed in the office to allow the patient to experience monovision correction. Lenses are fit according to the directions in the general fitting guidelines and base curve selection described earlier in the guide. Case history and standard clinical evaluation procedure should be used to determine the prognosis. Determine which eye is to be corrected for distance and which eye is to be corrected for near. Next determine the near add. With trial lenses of the proper power in place observe the reaction to this mode of correction. Immediately after the correct power lenses are in place, walk across the room and have the patient look at you. Assess the patient s reaction to distance vision under these circumstances. Then have the patient look at familiar near objects such as a watch face of fingernails. Again assess the reaction. As the patient continues to look around the room at both near and distance objects, observe the reactions. Only after these vision tasks are completed should the patient be asked to read print. Evaluate the patient s reaction to large print (eg. typewritten copy) at first and then graduate to news print and finally smaller type sizes. After the patient s performance under the above conditions is completed, tests of visual acuity and reading ability under conditions of moderately dim illumination should be attempted. An initial unfavorable response in the office, while indicative of a guarded prognosis, should not immediately rule out a more extensive trial under the usual conditions in which a patient functions. 6. Adaptation Visually demanding situations should be avoided during the initial wearing period. A patient may at first experience some mild blurred vision, dizziness, headaches, and a feeling of slight imbalance. You should explain the adaptational symptoms to the patient. These symptoms may last for a brief minute or for several weeks. The longer these symptoms persist, the poorer the prognosis for successful adaptation. To help in the adaptation process the patient can be advised to first use the lenses in a comfortable familiar environment such as in the home. Some patients feel that automobile driving performance may not be optimal during the adaptation process. This is particularly true when driving at night. Before driving a motor vehicle, it may be recommended that the patient be a passenger first to make sure that their vision is satisfactory for operating an automobile. During the first several weeks of wear (when adaptation is occurring), it may be advisable for the patient to only drive during optimal driving conditions. After adaptation and success with these activities, the patient should be able to drive under other conditions with caution. 7. Other suggestions

12 The success of monovision technique may be further improved by having your patient follow the suggestions below: Having a third contact lens (distance power) to use when critical distance viewing is needed. Having a third contact lens (near power) to use when critical near viewing is needed. Having supplemental spectacles to wear over monovision contact lenses for specific visual tasks may improve the success of monovision correction. This is particularly applicable for those patients who cannot meet state licensing requirements with a monovision correction. Make sure of proper illumination when carrying out visual tasks. Success in fitting monovision can be improved by the following suggestions: Reverse the distance and near eyes if a patient is having trouble adapting. Refine the lens power if there is trouble with adaptation. Accurate lens power is critical for presbyopic patients. Emphasize the benefits of the clear near vision in straight-ahead and upward gaze with monovision. The decision to fit a patient with a monovision correction is most appropriately left to the eyecare practitioner in conjunction with the patient after carefully considering the patient s needs. All patients should be supplied with a copy of the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens Patient Instruction/ Wearer s Guide. PATIENT LENS CARE DIRECTIONS: Eyecare practitioners should review with the patient lens care directions, including both basic lens care information and specific instructions on the lens care regimen recommended for the patient: General Lens Care (To First Clean and Rinse, Then Disinfect Lenses) Basic Instructions: Care of contact lens takes very little time and involves THREE essential steps - CLEANING, RINSING AND DISINFECTING. Each step in itself is important, and one step is not to be replaced by the other. Always wash, rinse and dry hands before handling contact lens. Always use FRESH, STERILE UNEXPIRED lens care solutions. Page 12 of 16

13 Use the recommended lens care system; either chemical (not heat) or heat (thermal). Different solutions cannot always be used together, and not all solutions are safe for use with all lens. DO NOT ALTERNATE OR MIX LENS CARE SYSTEMS UNLESS INDICATED ON SOLUTION LABELING. Do not use saliva or anything other than the recommended solutions for lubricating or rewetting lens. Do not put lens in the mouth. Lens should be cleaned, rinsed, and disinfected each time they are removed. Cleaning and rinsing are necessary to remove mucus and film from the lens surface. Disinfecting is necessary to destroy harmful germs. Always remove, clean, rinse, enzyme (as recommended by the eyecare practitioner) and disinfect lenses according to the schedule prescribed by the eyecare practitioner. The use of an enzyme or any cleaning solution does not substitute for disinfection. The eyecare practitioner should recommend a care system that is appropriate for eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens. Each lens care product contains specific directions for use and important safety information, which should be read and carefully followed. Note: Some solutions may have more than one function, which will be indicated on the label. Read the label on the solution bottle, and follow instructions. Lens cleaning, disinfection, and storage: o Clean one lens first (always the same lens first to avoid mix-ups), rinse the lens thoroughly with recommended rinsing or disinfecting solution to remove the cleaning solution, mucus, and film from the lens surface, and put lens into correct chamber of the lens storage case. Then repeat the procedure for the second lens. o After cleaning, disinfect lens using the system recommended by the manufacture and/or the eyecare practitioner. o To store lens, disinfect and leave them in the closed/unopened case until ready to wear. If lens is not to be used immediately following disinfection, the patient should be instructed to consult the package insert or the eyecare practitioner for information on storage of lens. Follow the instruction and timing recommended by the solution manufacturer. o After removing the lens from the lens case, empty and rinse the lens storage case with solution as recommended by the lens case manufacturer; then allow the lens case to air dry. When the case is used again, refill it with storage solution as recommended by the lens case manufacturer; or your eyecare practitioner. o Eyecare practitioners may recommend a lubricating/rewetting solution which can be used to wet (lubricate) lens while they are being worn to make them more comfortable. Page 13 of 16

14 Chemical (NOT HEAT) Lens Disinfection: 1. Wash and rinse your hands thoroughly BEFORE HANDLING LENS. 2. After removal of lens, CLEAN the lens by applying three drops of cleaner to each surface. Then rub the lens between your fingers for 20 seconds. 3. AFTER CLEANING, thoroughly rinse both surfaces of the lens with a steady stream of fresh, sterile rinsing solution for approximately 10 seconds. 4. Fill contact lens carrying case with the recommended disinfection and storage solution and place lens in the proper cells for a minimum of 4 hours. Follow the instruction and timings recommended by the manufacturer or eyecare practitioner. 5. When use hydrogen peroxide lens care systems, lenses must be neutralized before wearing. Follow the recommendations on the hydrogen peroxide system labeling. 6. Thoroughly rinse lens with a fresh solution recommended for rinsing before inserting and wearing, or follow the instructions on the disinfection solution labeling. 7. Leave the lens in the unopened storage case until ready to put on the eyes. Note: DO NOT HEAT THE DISINFECTION SOLUTION AND LENS. Caution: Lenses that are chemically disinfected may absorb ingredients from the disinfecting solution, which may be irritating to the eyes. A thorough rinse in fresh, sterile rinsing solution prior to placement on the eye should reduce the potential for irritation. Lens Care Regimen: Patients must adhere to the lens care regimen recommended by their eyecare practitioner for the eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens. Failure to follow this procedure may result in development of serious ocular infections Storage: The eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens must be stored only in the recommended solutions. If left exposed to the air, the lens will dehydrate. If lens dehydrates, reference above section on caring for dried out (dehydrated) dry lens. Lenses prescribed for frequent replacement: The eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens may be prescribed in a frequent replacement program and should be thrown away after the recommended wearing period prescribed by the eyecare practitioner. Page 14 of 16

15 Lens Deposits and Use of Enzymatic Cleaning Procedure: Enzyme cleaning may be recommended by the eyecare practitioner. Enzyme cleaning removes protein deposits on the lens. These deposits cannot be removed with regular cleaners. Removing protein deposits is important for the well being of the patient's lens and eyes. If these deposits are not removed, they can damage the lens and cause irritation. Enzyme cleaning does NOT replace routine daily cleaning and disinfecting. For enzyme cleaning, the patient should carefully follow the instructions in the enzymatic cleaning labeling. Care for a Dehydrated Lens: If for some reason, your lens dry out completely a minimum of handling is important, as they are very brittle in the dehydrated state. Carefully place them in rinsing or storage solution for a minimum of thirty minutes during which time they will become soft and flexible. Then follow the cleaning, rinsing, and disinfecting procedures - including soaking the lens in storage and disinfection solution for four hours before wearing again. Care for a Sticking (Nonmoving) Lens: If the lens sticks (cannot be removed), the patient should be instructed to apply 3 to 4 drops of the recommended lubricating or rewetting solution directly to the eye and wait until the lens begins to move freely on the eye before removing it. If non-movement of the lens continues after 15 minutes, the patient should IMMEDIATELY consult the eyecare practitioner. EMERGENCIES: The patient should be informed that if any chemical of any kind (household products, gardening solutions, laboratory chemicals, etc) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT YOUR EYECARE PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. REPORTING OF ADVERSE REACTIONS: Practitioners should report any adverse reactions to eyedia precise monthly for astigmatism (Hioxifilcon A) Soft Contact Lens within 5 days to the address below. Page 15 of 16

16 Additional Package Insert and Patient Instruction/ Wearer s Guide are available from: Clearlab US Inc Jenkins Court, Suwanee, GA 30024, United States of America Tel: Fax: USRA@clearlab.com Website: HOW SUPPLIED: Each lens is supplied sterile in blister packs in bicarbonate buffered aqueous solution with poloxamer. The blister pack is marked with the base curve, diameter, dioptric power, manufacturing lot number and expiration date of the lens. SYMBOLS KEY: The following symbols may appear on the label or carton. SYMBOL LOT EXP BC DIA CYL AXIS SINGLE PATIENT USE DESCRIPTION Sterile Using Steam Product Lot Number Expiry Date Lens Base Curve Lens Diameter Lens Cylinder Lens Axis Caution: Federal law restricts this device to sale by or on the order of a licensed Eye Care Practitioner. Caution: This is a single patient use device; See Package Insert or Instructions For Use. Clearlab US Inc Printed in Singapore Revision Date: 20 October 2011 Doc Number: S-ASP-025-A Version Number: V CLEARLAB SG PTE. LTD. All Rights Reserved. Page 16 of 16